Head and Neck CancerPhase 3NCT00120211
Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer
A Phase 3 study testing Accelerated Radiotherapy Fractionation in people with Head and Neck Cancer, run by International Atomic Energy Agency.
Trial summary
This trial compares the use of 6 fractions versus the standard 5 fractions of radiotherapy used in the treatment of head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Accelerated Radiotherapy Fractionation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 855 participants
- Where
- No sites listed yet
- Study dates
- Sep 1998to May 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Head and Neck Cancer
Who cannot join
- Unable to give an informed consent
About this study
Official title: Phase III Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer
This trial compares the use of 6 fractions versus the standard 5 fractions of radiotherapy used in the treatment of head and neck cancer.
Read the detailed description
The purpose of this trial is to study the clinical effects of increasing the weekly fraction number for locally advanced head and neck cancers by a multi-institutional prospective randomised trial. The primary endpoint is to clarify whether a six fraction per week protocol has a greater effect on the survival, as compared to the conventional five fraction per week protocol.
- Conditions
- Head and Neck Cancer
- Being tested
- Accelerated Radiotherapy Fractionation
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated Radiotherapy FractionationRadiation
Radiation Therapy 6 fractions per week
Accelerated Radiotherapy FractionationRadiation
Radiotherapy 5 fractions per week
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy: 6 Fractions | Experimental | Not described Receives: Radiation: Accelerated Radiotherapy Fractionation |
| Radiotherapy: 5 fractions | Active comparator | Not described Receives: Radiation: Accelerated Radiotherapy Fractionation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three Years Loco-regional Control
Measured: 3 years
Secondary outcomes (4)
Disease-specific Survival
Measured: 8 years
Overall Survival
Measured: 8 years
Acute Adverse Effects
Late Adverse Effects
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2005 (estimated)
- Study startSep 1998
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 855 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Atomic Energy Agency
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eduardo Rosenblatt, M.D., Study director, International Atomic Energy Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120211
- Sponsor's protocol ID
- E33018
- Status last verified
- Oct 2011
- First submitted
- 8 Jul 2005
- Last updated
- 13 Oct 2011
- Results posted
- No
Publications
Overgaard J, Mohanti BK, Begum N, Ali R, Agarwal JP, Kuddu M, Bhasker S, Tatsuzaki H, Grau C. Five versus six fractions of radiotherapy per week for squamous-cell carcinoma of the head and neck (IAEA-ACC study): a randomised, multicentre trial. Lancet Oncol. 2010 Jun;11(6):553-60. doi: 10.1016/S1470-2045(10)70072-3. Epub 2010 Apr 8.
PubMed 20382075
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00120211
- Acronym / sponsor ID
- E33018
- Conditions
- Head and Neck Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 855 participants (actual)
- Lead sponsor
- International Atomic Energy AgencyOther government
- Study start
- Sep 1998
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 15 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial compares the use of 6 fractions versus the standard 5 fractions of radiotherapy used in the treatment of head and neck cancer.
Detailed description
The purpose of this trial is to study the clinical effects of increasing the weekly fraction number for locally advanced head and neck cancers by a multi-institutional prospective randomised trial. The primary endpoint is to clarify whether a six fraction per week protocol has a greater effect on the survival, as compared to the conventional five fraction per week protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy: 6 Fractions | Experimental | Radiation: Accelerated Radiotherapy Fractionation |
| Radiotherapy: 5 fractions | Active comparator | Radiation: Accelerated Radiotherapy Fractionation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Head and Neck Cancer
Key exclusion criteria (1 listed)
- Unable to give an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated Radiotherapy FractionationRadiation Therapy 6 fractions per week | Radiation | Radiotherapy: 6 Fractions |
| Accelerated Radiotherapy FractionationRadiotherapy 5 fractions per week | Radiation | Radiotherapy: 5 fractions |
Primary outcome
Three Years Loco-regional Control
Time frame: 3 years
4 secondary outcomes
Disease-specific Survival
Time frame: 8 years
Overall Survival
Time frame: 8 years
Acute Adverse Effects
Late Adverse Effects
Time frame: 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2011.
- Derived from this study: PubMed 20382075Overgaard J, Mohanti BK, Begum N, Ali R, Agarwal JP, Kuddu M, Bhasker S, Tatsuzaki H, Grau C. Five versus six fractions of radiotherapy per week for squamous-cell carcinoma of the head and neck (IAEA-ACC study): a randomised, multicentre trial. Lancet Oncol. 2010 Jun;11(6):553-60. doi: 10.1016/S1470-2045(10)70072-3. Epub 2010 Apr 8.
- International Atomic Energy Agency, Research Contracts AdministrationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Rosenblatt, M.D. study director
International Atomic Energy Agency
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Accelerated Radiotherapy Fractionation in people with Head and Neck Cancer, run by International Atomic Energy Agency.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three Years Loco-regional Control (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00120211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2011.